On February 3, 2017 Tactiva Therapeutics LLC, a new biotech company spun off from Roswell Park Cancer Institute, will create jobs as it develops some of the most promising concepts in the burgeoning field of cancer immunotherapy and accelerates the timeline for getting beneficial therapies to patients (Press release, Roswell Park Cancer Institute, FEB 3, 2017, View Source [SID1234518860]).

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Founded by a trio of Buffalo entrepreneurs, Tactiva will pursue and expand concepts originating from Roswell Park’s Center for Immunotherapy. Located within the New York State Center of Excellence in Bioinformatics and Life Sciences, immediately adjacent to Roswell Park laboratories and research support facilities, the company will create employment opportunities within the life sciences and develop new therapies designed to give cancer patients better, more effective treatment options.

"The new biotech company spun off from Roswell Park Cancer Institute showcases the potential for New York innovation to impact lives around the world," said Lieutenant Governor Hochul during an announcement at Roswell Park today. "Tactiva Therapeutics is a perfect example of how government, business and academia can join forces to accomplish great things, including creating more jobs for Western New York."

Tactiva’s lead platform is a unique approach to adoptive cell transfer (ACT), a form of immunotherapy in which a patient’s own immune cells are drawn from blood, genetically engineered, multiplied and injected back into the patient in order to launch a powerful attack against cancer. Tactiva’s novel therapies use particular types of immune cells and cell reengineering processes that have never been employed before, in a way that may prove beneficial for patients with many different kinds of cancer.

There are two main types of T cells, or T lymphocytes, within the immune system — the so-called "helper" T cells, and the "killer" T cells. Through preclinical studies at Roswell Park, the Tactiva team developed a way to make "helper" CD4 T cells also act as "killer" CD8 T cells that can destroy tumor cells, significantly extending the durability of the antitumor response.

"We’re using fundamental principles of how the immune system works to enhance the body’s own ability to attack and eliminate cancer cells," says Tactiva Co-Founder and Chief Medical Officer Kunle Odunsi, MD, PhD, FRCOG, FACOG, also Deputy Director, Chair of Gynecologic Oncology and Center for Immunotherapy Executive Director at Roswell Park. "We’re making the two main types of immune cells work together in a way that has never been tried before, and which we believe will have long-lasting effects for patients with some of the most persistent, hard-to-treat cancers."

Tactiva plans to initiate a clinical trial within the next year that will make this novel platform available to patients for the first time. Preclinical studies suggest that the Tactiva platform may be an effective approach for treating several different solid and liquid tumors, including some ovarian, pancreatic, prostate, lung, esophageal, melanoma and sarcoma cancers, as well as some forms of multiple myeloma.

"We will take a patient’s own stem cells, hematopoietic stem cells that are the progenitors of all other blood cells, and engineer them to express specialized T-cell receptors that recognize and target cancer cells without damaging healthy cells," adds Richard Koya, MD, PhD, Co-Founder and Chief Scientific Officer for Tactiva as well as Associate Director of the Roswell Park Center for Immunotherapy. "The self-perpetuating nature of the stem cells gives them the ability to provide lifelong protection against cancer, standing on guard like a sentry. While much will depend on our early clinical trials, we believe this may be a highly effective way to deliver a lethal and enduring hit to the tumor cells."

"This is a potent combination of benefits, and our team’s preclinical findings convince us that this is a highly promising approach for treating cancer and keeping it at bay for many years," says Tactiva co-founder and Chief Executive Officer Matthew Colpoys Jr., who has held numerous leadership positions during his three decades working in the pharmaceutical and medical-technology industries.

This strategy is a broadly applicable model that may, if it proves to be effective, be adapted to many different antigens and employed in a variety of different cancers, notes Dr. Odunsi, who is also Professor of Gynecology & Obstetrics in the University at Buffalo’s Jacobs School of Medicine and Biomedical Sciences.

The foundational concepts that Tactiva will develop were established in large part thanks to grants to Dr. Odunsi and his team totaling $25 million from the National Cancer Institute and New York State Stem Cell Science Program (NYSTEM).

"We’ve been excited about immunotherapy for a long time because of its great potential in treating cancer and improving quality of life for cancer patients," says Roswell Park President and CEO Candace Johnson, PhD. "Tactiva has developed a unique approach that shows great promise, advancing one of our key goals: to develop our best ideas and get them quickly to the patients who can benefit most from them."

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About Roswell Park:
The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. Founded in 1898, RPCI is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-877-ASK-RPCI (1-877-275-7724) or email [email protected]. Follow Roswell Park on Facebook and Twitter.

About Tactiva Therapeutics LLC:
Tactiva Therapeutics is an immuno-oncology company specializing in potent cancer immunotherapy using a dual T cell receptor approach. For more information, visit www.tactivatherapeutics.com

On February 3, 2017 FibroGen, Inc., (NASDAQ:FGEN), a science-based biopharmaceutical company, reported that clinical results from the company’s open-label, dose-escalation Phase 1/2 study (FGCL-MC3019-028) of pamrevlumab in pancreatic cancer were published in the Journal of Cancer Clinical Trials (Picozzi et al., J Cancer Clin Trials 2017, 2:123) (Press release, FibroGen, FEB 3, 2017, View Source [SID1234517629]). The published results support a dose-related increase in survival in advanced pancreatic cancer, and that pamrevlumab can be safely combined with chemotherapy. Pamrevlumab is first-in-class fully human monoclonal therapeutic antibody that inhibits connective tissue growth factor (CTGF), a common factor in chronic fibrotic and proliferative disorders.

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"The data showing improved survival with pamrevlumab suggest a role for CTGF in the interactions of cancer cells and stroma responsible for tumor proliferation in PDAC," said Vincent J. Picozzi, Jr., M.D., Director of the Pancreas Center, Virginia Mason Hospital & Seattle Medical Center and lead author. "These results provide further support for the clinical evaluation of pamrevlumab in combination with chemotherapy, and evidence that pamrevlumab can be safely combined with chemotherapy without incremental toxicity in advanced pancreatic cancer patients."

In the 028 trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events. Toxicity, tumor response by CA19-9 and CT scan-based RECIST criteria, progression-free survival (PFS) and overall survival (OS) were assessed. In a post-hoc analysis, FG-3019 trough plasma levels (a measure of exposure) on Day 15 (D15Cmin) and baseline CTGF levels were correlated with clinical outcomes. High FG-3019 exposure (D15 Cmin ≥150 μg/mL) was associated with improved median OS (9.0 vs 4.4 months, (D15 Cmin <150 μg/mL), p=0.024), and one-year OS rate (34.2% vs. 10.8%, respectively, p=0.026), respectively. Plasma CTGF showed potential as a prognostic biomarker, as low baseline CTGF levels (<10 ng/mL) were associated with improved OS (10.1 vs 4.4 months (≥10 ng/mL), p=0.028).

About Pancreatic Ductal Adenocarcinoma and Connective Tissue Growth Factor

Pancreatic ductal adenocarcinoma (PDAC), or pancreatic cancer, is the fourth leading cause of cancer deaths in the United States. According to the National Cancer Institute, in 2016, there were approximately 53,000 new cases of pancreatic cancer projected in the United States alone. Pancreatic cancer is aggressive and typically not diagnosed until it is largely incurable. Most patients are diagnosed after the age of 45, and overall five-year survival is about 7%, due to many factors, including advanced stage at diagnosis and limited response to currently available therapies (View Source). PDAC tumors often exhibit a high degree of desmoplasia, characterized by extensive connective tissue stroma and elevated levels of Connective Tissue Growth Factor (CTGF). Cancer-stroma interactions affect tumorigenesis, angiogenesis, resistance to therapy and metastatic spread of tumor cells. CTGF is overexpressed in PDAC and facilitates local desmoplasia, tumor progression and metastasis in animal models.

About Pamrevlumab

Pamrevlumab (FG-3019) is an investigational therapeutic antibody developed by FibroGen to inhibit the activity of CTGF, a common factor in chronic fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. FibroGen is currently conducting clinical studies of pamrevlumab in idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy.

In desmoplastic, or fibrotic, cancers such as pancreatic cancer, CTGF in the extensive fibrous stroma associated with the tumor promotes abnormal proliferation of stromal cells and tumor cells.

On February 3, 2017 Merck & Co (NYSE:MRK), known as MSD outside the United States and Canada, reported that the U.S. Food and Drug Administration (FDA) has accepted for review two supplemental Biologics License Applications (sBLAs) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in patients with locally advanced or metastatic urothelial cancer, a type of bladder cancer (Press release, Merck & Co, FEB 3, 2017, View Source [SID1234517626]). Specifically, the application for first-line use was accepted and granted Priority Review for the treatment of these patients who are ineligible for cisplatin-containing therapy. The application for second-line use was also accepted and granted Priority Review for these patients with disease progression on or after platinum-containing chemotherapy. The PDUFA, or target action, date for both applications is June 14, 2017.

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"Over the past 30 years, there have been very few clinical advances in the treatment of bladder cancer," said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. "The data with KEYTRUDA administered to patients with advanced urothelial cancer are promising, and we look forward to working with the FDA throughout the review process with the goal of bringing KEYTRUDA to patients who may benefit as quickly as possible."

The FDA previously granted Breakthrough Therapy Designation to KEYTRUDA for the second-line treatment of patients with locally advanced or metastatic urothelial cancer with disease progression on or after platinum-containing chemotherapy.

The applications, which are seeking approval for KEYTRUDA (pembrolizumab) monotherapy at a dose of 200 mg administered intravenously every three weeks, are based on data from the phase 2 KEYNOTE-052 trial and the phase 3 KEYNOTE-045 trial, respectively. KEYNOTE-052 is an open-label study investigating KEYTRUDA as a first-line treatment in patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin-containing therapy. KEYNOTE-045 is a randomized study investigating KEYTRUDA as a second-line therapy compared to investigator-choice chemotherapy (paclitaxel, docetaxel, vinflunine) in patients with locally advanced or metastatic urothelial cancer that has recurred or progressed on or after platinum-containing chemotherapy. In October 2016, the company announced that, although it did not show significant improvement in progression-free survival, the trial met its co-primary endpoint of overall survival (OS) and was stopped early at the recommendation of an independent Data Monitoring Committee (DMC).

KEYTRUDA is being evaluated in over 30 tumor types in more than 400 clinical trials, at least half of which combine KEYTRUDA with other cancer treatments.